Clinical Data Manager Position Open Job in CAMBRIDGE 02139, Massachusetts US
Location: NA NA
Total applied: 40
DUTIES & RESPONSIBILITIES - Represents Data Management on Clinical Trial Working Groups- Designs CRF and clinical database structures for data acquisition and data entry- Identifies and resolves data flow process issues in collaboration with the project team- Defines data handling conventions, edit checks, quality acceptance and auditing criteria for electronic data as well as procedures for handling exceptions for violations to the standard metadata and identifies and requests additions to standard metadata- Creates standard and ad hoc reports to efficiently identify outstanding queries, query types per site, etc.- Resolves discrepancies and unresolved issues that arise during data entry- Assesses and reports on data outlier values- Identifies and reconciles SAEs- Identifies areas of manual data review where electronic checks are not effective- Uses available tools, systems and processes in support of the coding of medical terms- Communicates with vendors to define required file format and content specifications for electronic files and establishes schedule and process for data transfers- Participates in the identification, review and evaluation of new data management technologies- Performs accurate database updates and follows up on query responses and errors identified in data cleaning- Drafts new Data Management Plans based on templates and Plans for similar protocol types- Documents database changes in the automated system audit trails and paper and electronic documentation- Liaises with third-party vendors such as CROs, EDC vendors and central laboratories in a project-manager capacity- Monitors timelines to ensure data management-related deadlines are met- Participates in the development and maintenance of Standard Operating Procedures (SOPs) and Process Guides related to data management activities Years Experience 3-5 YearsWorking hours: 8:30-5:30QUALIFICATIONS Basic qualifications: BS degree with 4+ years or MS degree with 2+ years of experience in clinical data management, preferably in the pharmaceutical/-biotechnology industry; knowledge of GCP, regulatory and ICH guidelines as applicable to clinical data management.
Preferred qualifications: Strong knowledge of SOPs, GCP standards and CDM systemsDetail orientedFundamental understanding of multiple computer applicationsRandstad is a world leader in matching great people with great companies.
Our experienced agents will listen carefully to your employment needs and then work diligently to match your skills and qualifications to the right job and company.
Whether you're looking for temporary, temporary-to-permanent or permanent opportunities, no one works harder for you than Randstad.
« Apply for Clinical Data Manager Position Open Job in CAMBRIDGE 02139, Massachusetts US
WARNING! Employers Check Your Credit Score!
Having a low credit score can cost you a job. Almost 50% of all companies run credit checks before hiring. What you need to do to in order to be safe:
1) See Your Credit Report - check if all information is correct and update it if necessary
2) Free Credit Score - check your updated credit score and discover how to improve it
3) Credit Monitoring and Protection - start your free trial today for protection against Identity Theft and to keep an eye on your Credit Score
4) Next Step - Get Your Free Credit Score Now!
Do you want to continue your education?
|
|